Title I of the Toxic Substances Control Act (TSCA) sets forth the process through which “new” chemical substances are introduced into commerce, and provides for testing and evaluation of existing chemical substances under certain circumstances. TSCA’s general chemical regulatory framework is criticized by the environmental community for “grandfathering” existing chemical substances without testing, and for requiring that the Environmental Protection Agency clear high hurdles before taking action with respect to existing chemical substances.
Meanwhile, the regulated community has increasingly criticized the current regime for failing to provide comfort to the public that the various chemicals in use have been tested and found safe. While various TSCA reform proposals have been put forth over the years, the core provisions of TSCA Title I are essentially unchanged since its enactment in 1976.
In May of this year, Senators Frank Lautenberg (D-N.J.) and David Vitter (R-La.) introduced the Chemical Safety Improvement Act (CSIA) in the Senate Environment and Public Works Committee. The CSIA now has over 20 co-sponsors, roughly evenly split between parties. A companion bill to CSIA has not been introduced in the House of Representatives, but the Subcommittee on Environment and the Economy has held three hearings on TSCA so far this Congress. A variety of stakeholders endorse CSIA as a vehicle for updating TSCA, but several points of friction remain.
Overview Of Current Law
The TSCA regulates the manufacture, distribution and use of “chemical substances,” a term defied very broadly to mean “any organic or inorganic substance of a particular molecular identity” including those found in nature. The TSCA does not apply to chemical substances regulated under other federal programs (e.g., drugs, pesticides).
New Chemical Substances
The TSCA treats chemical substances very differently depending on whether they are “new” to commerce or already distributed in commerce (discussed below as “existing” chemical substances). Chemical substances already in commerce appear on the TSCA Inventory, while those not yet on the inventory are considered new. Before producing a new chemical substance for commercial purposes, the manufacturer must file a pre-manufacture notice (PMN) with the EPA describing the chemical’s identity, proposed uses and potential exposure pathways, among other details.
If the EPA notifies the manufacturer that manufacture may commence (or if the 90-day review period passes without comment) the manufacturer may begin producing the chemical for commercial purposes. Once manufacture does commence, the manufacturer is required to submit a Notice of Commencement. After the notice is submitted, the chemical substance is added to the inventory and is no longer considered a new substance.
If the EPA determines that use of the chemical substance may present unreasonable risks to human health or the environment, it may issue a Significant New Use Rule (SNUR). The SNUR describes permitted uses and delineates which potential future uses would require approval by the EPA. Often the SNUR simply limits allowed uses of the chemical substance to those described in the pre-manufacture notice. If a manufacturer wishes to produce the chemical substance for purposes beyond those allowed by the SNUR, it must submit a Significant New Use Notice, which is essentially equivalent to a pre-manufacture notice. The manufacturer may not produce the chemical substance for the proposed new use unless approved by the EPA.
Existing Chemical Substances
When the TSCA was enacted in 1976, chemical substances then in commerce were added to the inventory. In general, chemical substances on the inventory may be produced by any party for any use without going through the evaluation for new chemical substances described above. The EPA does have the opportunity to collect safety data — manufacturers and processors of existing chemical substances are required to report results of safety studies and any adverse events related to the chemical substance to the EPA, and the EPA is authorized to mandate safety testing of existing chemicals.
If the EPA finds that there is a “reasonable basis to conclude” that the manufacture, processing, distribution, use, or disposal of a chemical substance presents an “unreasonable risk of injury to health or the environment,” the EPA may restrict (or even ban) the manufacture and use of the chemical substance. The EPA may only impose restrictions relative to a chemical substance to the “extent necessary to protect adequately against such risk using the least burdensome requirements” under the current TSCA regime.
In practice, the EPA has rarely used its authority to restrict existing chemicals under the TSCA. Famously, in the 1991 case Corrosion Proof Fittings v. EPA, the U.S. Court of Appeals for the Fifth Circuit overturned rules phasing out (and then banning) asbestos. Under the court’s reasoning, the EPA had not adequately shown that a ban on asbestos was the least burdensome means of addressing the risks presented. The Corrosion Proof Fittings case is often cited by stakeholders arguing for greater EPA authority to restrict existing chemicals.
2013 Proposed Legislation
The Chemical Safety Improvement Act would maintain many of the features of TSCA, including the current process with respect to new chemicals. Several key differences between TSCA and CSIA are discussed below.
Policy And Scope
The TSCA’s stated policy goal is to “regulate chemical substances and mixtures which present an unreasonable risk of injury to health or the environment” and to address “imminent hazards” posed by the use of chemical substances. While the CSIA is also built around the policy framework of protection against unreasonable risk, it includes the policy statement that chemicals “should be safe” for their intended use. This may presage an enforcement philosophy geared more towards the precautionary principle than the current regime (in brief, the precautionary principle states that those proposing to take an action that may have adverse impacts on human health or the environment bear the burden of showing that it will not be harmful).
Evaluation Of Existing Chemicals
As noted above, some stakeholders fault TSCA for “grandfathering” existing chemicals without a systematic evaluation of safety. The CSIA would address this concern by requiring safety evaluations of certain existing chemicals. As a first step, the EPA would be required to designate existing chemicals as “high” or “low” priority for evaluation. This priority designation would be subject to public notice and comment, but would not be considered a judicially reviewable final agency action.
Those chemicals identified as high priority by the EPA would be subject to a safety assessment. The CSIA sets forth detailed guidelines on how safety assessments are to be conducted, including the directive that the EPA “shall employ the best available science and risk assessment principles in existence at the time” in evaluating chemicals. Following the safety assessment, the EPA would be required to promulgate rules, as appropriate, to mitigate risks presented by the substance. These rules may vary in their impact from labeling requirements and production limits all the way to bans on production and use.
The CSIA’s stated policy goals include “promoting uniform protections” and “minimiz[ing] undue burdens on commerce” and state resources. To that end, CSIA’s preemption provisions are broader than the TSCA’s. Specifically, the CSIA would preempt existing and any proposed future state-level testing requirements or (after completion of EPA’s safety assessment) restrictions on the manufacture, processing or distribution of a chemical substance.
Further, the CSIA would preempt proposed future state-level restrictions on the manufacture, processing, or distribution of chemical substances unless the state obtains a waiver from the EPA. It is important to note, however, that the CSIA would not preempt state regulations promulgated pursuant to other federal programs (e.g., Clean Air Act, Clean Water Act).
While the CSIA has attracted the support and attention of a broad base of stakeholders, key points of friction remain. The CSIA’s preemption provisions are especially controversial and have been opposed by influential stakeholders, particularly from California. California has well-developed state programs regulating the manufacture and use of chemicals, some of which may be preempted if CSIA is enacted. Senator Barbara Boxer (D-Cal.) opposes the CSIA’s preemption provisions, and as chair of the Senate Environment and Public Works Committee she is uniquely well-positioned to shape the debate going forward. We can expect wrangling over preemption provisions to shape how, and whether, the CSIA will go forward.•